Clinical trials: Parenteral Nutrition
Nutritional Status, Malnutrition
Screening Day Latin America
This is a survey which will be performed on a specific day (the "Screening Day") in Latin American ICUs. In eligible patients who receive enteral or parenteral nutrition a retrospective calculation of the "caloric deficit" will…
- Conditions
- Nutritional Status, Malnutrition, Caloric Deficit
- Trial name
- NCT02583880
- Where
- 121 sites in Argentina, Brazil and 6 more
- Volunteers
- 1,162 people
- Sponsor
- Fresenius Kabi
Mucositis
Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690
Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc.
- Trial name
- NCT05658016
- Testing
- TK-112690
- Where
- 5 sites in India
- Volunteers
- 24 people
- Sponsor
- Tosk, Inc.
Parenteral Nutrition, Blood Stream Infection
Three-Chamber Bags Retrospective Study in Spain
The primary study objective is to assess the rates of blood stream infection (BSI) from the use of Three-Chamber Bags (e.g., SmofKabiven®, Kabiven®, others) compared to Hospital Compounded Bags (HCBs) in patients requiring…
- Trial name
- NCT03284398
- Where
- 2 sites in Spain
- Volunteers
- 3,723 people
- Sponsor
- Fresenius Kabi
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment…
- Trial name
- NCT02579265
- Testing
- Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Fresenius Kabi
Short Bowel Syndrome
Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome
The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.
- Trial name
- NCT03571516
- Testing
- Teduglutide, Standard Medical Therapy, Syringe
- Where
- 8 sites in Finland, France and 2 more
- Volunteers
- 10 people
- Sponsor
- Shire
Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
This study will demonstrate Short-, mid-, and long-term safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this…
- Conditions
- Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency, Neurocognitive Deficit, Malnutrition
- Trial name
- NCT04807478
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Sponsor
- Fresenius Kabi
Malnutrition
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
- Trial name
- NCT03481894
- Testing
- Kabiven®, Compounded standard parenteral nutrition
- Where
- 2 sites in United States
- Sponsor
- Fresenius Kabi
Heart Failure, Congestive
A Study of Iron Oligosaccharide in CHF Patients
The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with congestive heart failure with a need for parenteral iron.
- Trial name
- NCT00537186
- Testing
- Iron oligosaccharide
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Pharmacosmos A/S
Asthma
Systemic Corticosteroids Avoidance Study in Severe Asthma Patients
The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over…
- Trial name
- NCT03629249
- Testing
- QAW039 150 mg once daily, QAW039 450 mg once daily
- Where
- 120 sites in United States, Argentina and 19 more
- Volunteers
- 604 people
- Sponsor
- Novartis Pharmaceuticals
Manganese Safety in Adults
Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety
Tralement versus a fixed-dose trace element combination product of zinc, copper, and selenious acid to evaluate product safety in adult patients requiring long-term parenteral nutrition.
- Trial name
- NCT05661682
- Testing
- Tralement, Fixed-dose trace element combination product of zinc, copper, and selenious acid
- Sponsor
- American Regent, Inc.
Short Bowel Syndrome
Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes.
- Trial name
- STEPS (NCT00798967)
- Testing
- teduglutide
- Where
- 35 sites in United States, Canada and 8 more
- Volunteers
- 86 people
- Sponsor
- Shire
Obesity, Over-weight
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
- Conditions
- Obesity, Over-weight, Prader-Willi Syndrome
- Trial name
- NCT01818921
- Testing
- ZGN-440 sterile diluent, 1.2 mg ZGN-440 for injectable suspension, 1.8 mg ZGN-440 for injectable suspension
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Zafgen, Inc.
Patients Requiring Home Parenteral Nutrition
The HOME Study (HPN With OMEGA-3)
The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN.
- Trial name
- HOME (NCT03282955)
- Testing
- Lipidem, Lipofundin MCT 20%
- Where
- 9 sites in France, Italy and 3 more
- Volunteers
- 74 people
- Sponsor
- B. Braun Melsungen AG
Parenteral Nutrition
A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)
This is a phase 1, prospective, single-center, randomized sequence, double-blind, 2-way crossover, relative bioavailability study in healthy adult subjects comparing Sodium Glycerophosphate Injection (SGP) to Sodium Phosphate…
- Trial name
- NCT06842121
- Testing
- Sodium Glycerophosphate Injection, Sodium Phosphates Injection
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Short Bowel Syndrome, Parenteral Nutrition Associated Liver Disease
Study of NST-6179 in Healthy Subjects
A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.
- Trial name
- NCT05181085
- Testing
- NST 6179
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- NorthSea Therapeutics B.V.
Parenteral Nutrition
Different Lipid Emulsions in Acute Lung Injury Patients
Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit.
- Trial name
- NCT01814956
- Testing
- Lipoplus 20%, Lipofundin N 20%
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- B. Braun Melsungen AG
Carcinoma Surgery, Parenteral Nutrition
The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil emulsion on outcome in post-operative cancer patients.
- Conditions
- Carcinoma Surgery, Parenteral Nutrition, Post-Operative Hospital Stay
- Trial name
- NCT00292279
- Testing
- Omega-3 fish oil emulsion (Omegaven ), long-chain triglyceride
- Where
- 5 sites in China
- Volunteers
- 206 people
- Sponsor
- Sino-Swed Pharmaceutical Corporation
Obesity
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide.
- Trial name
- NCT06716307
- Testing
- CagriSema (cagrilintide B and semaglutide I), CagriSema A
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Novo Nordisk A/S
Intestinal Failure, Enterocutaneous Fistula
Chyme Reinfusion for Type 2 Intestinal Failure
This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas.
- Conditions
- Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma, High Output Stoma
- Trial name
- REINFUSE (NCT04577456)
- Testing
- The Insides System
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 44 people
- Sponsor
- The Insides Company
Parenteral Nutrition
A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E
This is a phase 1, prospective, single-center, randomized sequence, open label, 2-way crossover study comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E.
- Trial name
- NCT06842134
- Testing
- Numeta G16%E, Sodium Glycerophosphate Injection
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation